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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coro
Generic NameCoronary drug-eluting stent
ApplicantBoston Scientific Corporation
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP150003
Supplement NumberS097
Date Received08/04/2023
Decision Date08/17/2023
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Increasing the temperature range on the equipment that extrudes the SYNERGY balloon material.
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